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CTRI Number  CTRI/2023/10/058985 [Registered on: 20/10/2023] Trial Registered Prospectively
Last Modified On: 05/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of brain Gym exercise in addition to balance training vs balance training in balance in Parkinson patients 
Scientific Title of Study   Effect of brain gym exercise along with balance training versus balance training on fear of fall and balance in patients with Parkinsonism 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saylee Phatak 
Designation  MPT student  
Affiliation  sunandan divatia school of sciences  
Address  Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(W)

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  7045837544  
Fax    
Email  sayuphatak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sabah Thaver 
Designation  Assisstant professor- physiotherapist  
Affiliation  sunandan divatia school of sciences  
Address  Sunandan Divatia School of Science ,Vile Parle West. Bhaktivedanta Road

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9820691076  
Fax    
Email  Sabah.Thaver@nmims.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Sabah Thaver 
Designation  Assisstant professor- physiotherapist  
Affiliation  sunandan divatia school of sciences  
Address  Sunandan Divatia School of Science ,Vile Parle West. Bhaktivedanta Road

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9820691076  
Fax    
Email  Sabah.Thaver@nmims.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy ,ground floor, Nanavati Max SuperSpecality Hospital, sv Road, Vile parle west,  
 
Primary Sponsor  
Name  Dr. saylee phatak  
Address  sunandan divate school of sciences svkm, bhaktivedanta road vile parle west 400056 
Type of Sponsor  Other [self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr ali irani   Nanavati Max Super Specialty Hospital   department of physiotherapy ground floor,
Mumbai (Suburban)
MAHARASHTRA 
02261347560

physiodept.nanavati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nanavati max super speciality hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Balance Training   total 12 session thrice a week 
Intervention  Brain gym and Balance training   Total 12 session Thrice a week  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Indivisual diagonosed with Parkinsons and withclinical score up to 4 on Modified Hoehn and Yahr scale  
 
ExclusionCriteria 
Details  Indivisual with any other medical or recent surgical history which may prevent participation in study .
Indivisual with vision and auditory disorder.
Patients with cognitive challenges example :PD associated dementia. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Fall Efficacy Scale - International  Baseline ,post intervention and 1 month follow up 
 
Secondary Outcome  
Outcome  TimePoints 
mini BEST test   Baseline and postintervention. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   TITLE OF STUDY : Effect of brain gym exercise along with balance training versus balance training on fear of fall and balance in patients with parkinsonism .
INTRODUCTION : Parkinson’s disease is a progressive disorder of the central nervous system with both motor and non-motor symptoms that particularly affects movement. The clinical diagnosis of Parkinsonism is based primarily on motor features, such as a slowly progressive asymmetric resting tremor, rigidity and bradykinesia. Of all the symptoms Fear of Fall is often as the most stressful symptom.

Factors affecting fear of fall are Postural instability , Balance impairment and Lack of confidence . this fear of fall leading to restriction in mobility, Reduced fuctional Ability ,Reduced Functional independence and Social isolation .  

Brain gym (Education Kinesthetics) is an intervention by Mr. Paul and Mrs. Dennison in 1970 which by facilitating optimal achievement of mental potential and helps in the removal of stress, thereby supporting success, self-confidence creativity, communication, and organization .

It has been used in kids with a hyperactive vestibular system such as in ADHD, Autism Spectrum Disorders and Vestibular disorders to reduce their level of anxiety and stress.

They consist of 26 activities easy movements that are though to boost communication among the many nerve cells and functional centres located through the body and brain and are simple, cost effective way of managing stress and anxiety in controlled manner.

AIM: To determine the effect of brain gym exercise in addition to balance training versus  balance training on  fear of fall and balance in patients with parkinsonism .

OBJECTIVE :    

  1.   To evaluate the effect of balance exercises on fear of fall and balance on patients with Parkinson’s.
  2. To evaluate the effect of Brain Gym Exercises in adjunct to balance exercises on patients with Parkinson’s.
  3. To compare both the groups.

INCLUSION CRITERIA :

     Individuals diagnosed with Parkinson’s and with a clinical score upto 4 on Modified Hoehn and Yahr scale

EXCLUSION CRITERIA :

·       Individuals with any other medical or recent surgical history which may prevent participation in study

·     Individuals with vision or auditory disorders.

·     Patients with cognitive challenges example: PD associated dementia.

 
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